NCT04507607

Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in preventing mother-to-child transmission in pregnant women.Our purpose is to explore the TAF for CHB the curative effect of pregnant and postnatal security.

Detailed description

After diagnosis at the infection clinic of the Third Affiliated Hospital of Sun Yat-sen University, the eligible patients were enrolled into the group.Each person will sign the informed consent prior to enrollment.

Conditions

• Chronic Hepatitis B
• Mother-to-child Block
• Antiviral Treatment

Interventions

Type	Name	Description
DRUG	Tenofovir Alafenamide 25 MG	TAF was administered to pregnant women with CHB during pregnancy for mother-to-child interention.Women with chronic hepatitis B who are not pregnant receive TAF for antiviral treatment.

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-12-30
• Completion: 2021-06-30
• First posted: 2020-08-11
• Last updated: 2020-12-22

Locations

1 site across 1 country: China